• Bacterial infections

Bacterial infections:

Indications for ANTHRASIL:

Treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

Limitations of Use:

Has no direct antibacterial activity. Does not cross the blood-brain barrier. Does not prevent or treat meningitis. Pediatric, geriatric, or obese patients: not studied.

Adult:

Give by slow IV infusion using an infusion pump. Initial rate (1st 30mins): 0.5mL/min. Incremental rate if tolerated (every 30mins): 1mL/min. Max rate: 2mL/min. ≥17yrs: give 7 vials (420 Units). Base initial dose, adjustments, or repeat doses on clinical severity and response; severe cases may need 14 vials (840 Units). For substantial hemorrhage, significant compartmental fluid losses, or impaired/delayed immune response: consider initial dose of 840 Units and repeat dosing.

Children:

Give by slow IV infusion using an infusion pump. Initial rate (1st 30mins): 0.01mL/kg/min. Incremental rate if tolerated (every 30mins): 0.02mL/kg/min. Max rate: 0.04mL/kg/min (do not exceed Adult rate). <1–≤16yrs: give 1–7 vials (60–420 Units) based on patient weight (see full labeling). Base initial dose, adjustments, or repeat doses on clinical severity and response; severe cases may need 2–14 vials (based on weight) in those weighing >5kg.

Contraindications:

IgA-deficiency with antibodies against IgA and a history of IgA hypersensitivity.

Boxed Warning:

Interactions with glucose monitoring systems. Thrombosis.

Warnings/Precautions:

Have appropriate equipment, medication (including epinephrine), and trained personnel readily available for emergency care. Monitor and discontinue immediately if severe hypersensitivity reactions occur. Increased thrombosis risk in cardiovascular disorders, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheter, and/or known or suspected hyperviscosity; infuse at minimum rate practicable; monitor. Ensure adequate hydration. Consider baseline assessment of blood viscosity in those at risk of hyperviscosity, including cryoglobulins, chylomicronemia, markedly high triglycerides, or monoclonal gammopathies. Pre-existing renal insufficiency or risk of (eg, diabetes mellitus, age >65yrs, volume depletion, paraproteinemia, sepsis, taking nephrotoxic drugs); infuse at minimum rate practicable; monitor. Assess renal function, urine output, BUN, serum creatinine, prior to initial infusion and periodically thereafter; consider discontinuing if renal function deteriorates. Do not exceed recommended infusion rate. Monitor for infusion reactions; slow infusion rate or interrupt if occur. High doses (>2g/kg given as single dose or over several days), non-O blood group, or underlying inflammatory state; monitor for hemolysis. Consider measuring hemoglobin/hematocrit prior to infusion, within ~36–96hrs, and again ~7–10 days post-infusion. Perform neurological exam if signs/symptoms of aseptic meningitis syndrome develop (including CSF studies). Monitor for pulmonary adverse reactions; if transfusion-related acute lung injury (TRALI) suspected, perform appropriate tests. Contains human plasma; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.

Pharmacologic Class:

Immune globulin.

Interactions:

May falsely elevate glucose readings due to maltose content; use systems that are glucose-specific to test or monitor levels. May interfere with serological tests (eg, Coombs' test). May impair efficacy of live attenuated vaccines (eg, measles, rubella, mumps, varicella); defer until ~3 months after Anthrasil administration; revaccinate if Anthrasil was received shortly after live virus vaccination 3 months after Anthrasil administration.

Adverse Reactions:

Headache, infusion site pain and swelling, nausea, back pain; thrombosis, acute renal dysfunction/failure, hemolysis, aseptic meningitis syndrome, TRALI.

Generic Availability:

NO

How Supplied:

Single-dose vial (50mL)—1, 7